Drugs / GZR4
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07193147 | Oct 2025 → Jul 2026 overdue | diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07146347 | Aug 2025 → Apr 2026 overdue | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Recruiting | No outcome recorded |
| Phase 1 | NCT06547502 | Jul → Aug 2024 | diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT06548906 | May → Aug 2024 overdue | — | Gan and Lee Pharmaceuticals, USA | Recruiting | No outcome recorded |
| Phase 1 | NCT06553248 | Mar → Nov 2023 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT06548815 | Aug 2022 → Mar 2023 | diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT06202079 | Aug 2023 → Jul 2024 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | Met primary |
| Phase 34 trials · 3 met primary | ||||||
| Phase 3 | NCT07165223 | Oct 2025 → Nov 2026 expected | diabetes mellitus | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 3 | NCT06767761 | Feb 2025 → Mar 2026 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | Met primary |
| Phase 3 | NCT06767735 | Feb 2025 → Aug 2026 overdue | diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | Met primary |
| Phase 3 | NCT06767748 | Feb 2025 → Feb 2026 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06974487 Comparator | May → Sep 2025 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Gan and Lee Pharmaceuticals, USA | Results EASD 2026 Highlights | Pivotal Phase 3 SUPER-1 and SUPER-2 Studies of Once-Weekly Insulin ludefen Presented at EASD 2026, Demonstrating Superior Glycaemic Efficacy Compared to Once-Daily Basal Insulin ganlee.com ↗
At Week 26, once-weekly insulin ludefen demonstrated statistically superior reductions in glycated hemoglobin (HbA1c) compared with once-daily insulin glargine U100 and once-daily insulin degludec, respectively. |
| 2026-06-24 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Shines at CPHI China 2026, Securing Dual Honors for "R&D Innovation Awards" and "Sustainability Influencer Awards" ganlee.com ↗
Notably, the Company presented new clinical data at the recently concluded American Diabetes Association 86th Scientific Sessions (ADA 2026): The findings further support the use of bofanglutide and insulin ludefen injection |
| 2026-06-10 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Showcases Multiple Innovative Research Achievements at the American Diabetes Association’s 86th Scientific Sessions ganlee.com ↗
The findings further support the use of bofanglutide injection and insulin ludefen injection in patients with renal impairment. |
| 2026-06-05 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee’s Once-Weekly Basal insulin GZR4 Injection Met the Primary Endpoint in the Pivotal Phase 3 SUPER-3 Trial and Demonstrated Superior HbA1c Reduction Versus Insulin Glargine U100 ganlee.com ↗
The study results showed that after 26 weeks of treatment in combination with insulin aspart, once-weekly GZR4 injection demonstrated statistically significantly superiority in HbA1c reduction compared with once-daily insulin glargine U100. |
| 2026-05-29 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Attends the Multinational Diabetes Academic Conference 2026 ganlee.com ↗
Two pivotal Phase III clinical studies conducted in China, SUPER-1 and SUPER-2, successfully met their predefined primary endpoints. |
| 2026-03-30 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Once-Weekly Basal Insulin GZR4 Injection Meets Primary Endpoints in Two Pivotal Phase 3 Clinical Trials: SUPER-1 and SUPER-2 ganlee.com ↗
After 26 weeks of treatment, once-weekly GZR4 demonstrated statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c) * compared with once-daily insulin glargine U100 (Lantus ® ) and once-daily insulin degludec (Tresiba ® ). |
| 2025-07-01 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Presented Multiple Research Breakthroughs at the American Diabetes Association's 85th Scientific Sessions ganlee.com ↗
In a phase 2 clinical trial, the once-weekly insulin GZR4 injection demonstrated comparable efficacy and safety profiles than once-daily insulin degludec (Tresiba ® ) in patients with T2D after 16 weeks of treatment. |
| 2025-06-21 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association’s 85th Scientific Sessions ganlee.com ↗
In a Phase 2 clinical trial, the once-weekly insulin GZR4 injection demonstrated comparable efficacy and safety profiles in patients with T2DM after 16 weeks of treatment. |
| 2025-05-29 | Gan and Lee Pharmaceuticals, USA | Results Multinational Diabetes Academic Conference 2025 Opens in Beijing, Gathering Global Experts to Explore New Trends in Prevention and Treatment ganlee.com ↗
Multiple clinical studies indicate that GZR4 provides consistent glycemic coverage throughout the week, enabling effective once-weekly dosing. |
| 2024-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies ganlee.com ↗
After 16 weeks of treatment in patients with Type 2 diabetes, the once-weekly insulin analog GZR4 injection demonstrated superior HbA1c reduction in patients with uncontrolled diabetes on basal insulins, compared to insulin degludec (Tresiba ® ). |
| 2024-09-29 | Gan and Lee Pharmaceuticals, USA | Results [EASD 2024 Highlights] Once-weekly Insulin GZR4 ganlee.com ↗
After six weeks of treatment with once-weekly GZR4, patients with T2DM showed superior glycemic control compared to those receiving insulin degludec. |
| 2024-09-14 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Presented Two Positive Clinical Results of Once-weekly Insulin GZR4 at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD 2024) ganlee.com ↗
In Phase Ia clinical study, GZR4 demonstrated favorable safety and tolerability profiles in healthy subjects, maintaining a stable glucose-lowering effect for up to one week with a single administration. |
| 2024-07-11 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Successfully Shines at the American Diabetes Association's 84th Scientific Sessions ganlee.com ↗
both GZR4 and GZR101 showed excellent pharmacokinetic and pharmacodynamic characteristics in preclinical studies. |
| 2022-08-08 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for the innovative once-weekly ultra-long-acting insulin, GZR4 ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), is pleased to announce that the Food and Drug Administration (" FDA ") has cleared the Investigational New Drug (IND) application for GZR4 to conduct a Phase I clinical trial in the US (IND No. 159549). |
| 2022-07-08 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces IND Clearance by NMPA for the Ultra-Long Acting Insulin GZR4 ganlee.com ↗
China’s National Medical Products Administration (NMPA) has cleared its investigational new drug (IND) application for GZR4, to improve the management of diabetes. |
| 2021-11-30 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces NMPA Acceptance of Investigational New Drug (IND) for Once-Weekly Insulin GZR4 ganlee.com ↗
GZR4, once-weekly, long-acting insulin independently developed by Gan & Lee Pharmaceuticals, has received the Notice of Acceptance issued by the National Medical Products Administration (NMPA), for the treatment of diabetes. |
All press releases naming this drug 25 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GZR4 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06974487 ↗ |
| Known as | insulin GZR4 | “This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR4 (hereafter referred to as GZR4) and estimate its potency in...” NCT07146347 ↗ |
| Route | Subcutaneous | “GZR4 injection s.c.” NCT06202079 ↗ |